Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY HPLC - A REVIEW

Solat Sarala*, Purohit Gauri, Darandale Supriya, Mahor Nitesh, Dr. Vilas Sawale

ABSTRACT

This review focuses on approach to the validation of HPLC method with the compliance of restrictive needs and accepted pharmaceutical practices. The information during this review provides the explanations for performing analytical method validation. The validation parameters needed to be performed in validation for assay and organic impurities strategies. Individual validation parameters are mentioned in reference to the kind of method such assay and organic impurities method to be valid. This review was written to assist chemists/analysts to perform for method validation. This review study might facilitate to academics and pharmaceutical industry personnel to know the analytical method validation of HPLC as per USP and ICH guidelines.

Keywords: High-Pressure Liquid Chromatography (HPLC), Method validation, Method development, USP, ICH and Regulatory.